Predicting Outcomes of Breast-Conserving Surgery in Breast Cancer Patients Using the Modified 5-Item Frailty Index

Background: Breast cancer is the most common malignancy among women worldwide, with breast-conserving surgery (BCS) being a key treatment. The modified 5-item frailty index (mFI-5), a well-validated tool for assessing frailty, has shown predictive utility in other surgical contexts but remains under-explored in BCS.

Methods: Using the American College of Surgeons National Surgical Quality Improvement Program database (2008-2021), the investigators identified adult female breast cancer patients who underwent BCS. Frailty was assessed using the mFI-5, scored from 0 to 5, with higher scores indicating greater frailty. Multivariable logistic regression was employed to evaluate associations between mFI-5 scores and postoperative outcomes.

Main question: Can the mFI-5 predict adverse postoperative outcomes in breast-conserving surgery patients?

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Key information

Conditions

Retrospective Study

Sex eligibility

Female

Study type

Observational

Primary location

Technische Universität München

Munich, Bavaria, 81675, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Data from 14 annual datasets (2008-2021).
Female breast cancer patients identified using diagnostic codes:
ICD-9-CM 174: "Malignant neoplasm of female breast."
ICD-9-CM 233.0: "Carcinoma in situ of breast."
ICD-10-CM C50: "Malignant neoplasm of breast."
ICD-10-CM D05: "Carcinoma in situ of breast."
Focused on patients diagnosed with breast cancer.
Further refinement:
Only patients undergoing breast-conserving surgery (BCS).
Identified by CPT code 19301: "Partial mastectomy without axillary lymphadenectomy."

Exclusion criteria

Missing essential anthropometric data (height and/or weight).
Implausible BMI values (<7 kg/m² or >250 kg/m², assumed data entry errors).
Miscoded or vague ICD or CPT entries.
Concurrent invasive procedures other than BCS.
Procedures performed by specialties other than general or plastic surgery.
Male and non-binary patients or those with gender identity disorders (to focus on biologically female cohort).
Non-elective (emergency) surgical cases.
Patients with ASA physical status scores >4.
Patients receiving anesthesia types other than general anesthesia.

Treatment and study plan

Primary outcomes

General data

Time frame: 30 days
- Hospital length of stay (in days).
- Operative time (in minutes).
Any complications

Time frame: 30 days
- Patient mortality.
- (Unplanned) readmission.
- Surgical and/or medical complications.
Surgical Complications

Time frame: 30 days
- Infections (superficial, deep, or organ-space).
- Wound dehiscence.
- Bleeding requiring transfusion.
Medical Complications

Time frame: 30 days
- Pneumonia.
- Reintubation.
- Pulmonary embolism.
- Ventilator dependence >48 hours.
- Progressive renal insufficiency.
- Urinary tract infection.
- Stroke or cerebrovascular accident.
- Myocardial infarction.
- Deep vein thrombosis or thrombophlebitis.
- Sepsis.
- Septic shock.

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

Harvard Medical School (HMS and HSDM)

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jan 13, 2025
Registry last updated: Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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